Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Primary Sjögren's Syndrome

NCT02843659 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: IM128-0352016-000101-37
• Study Type: interventional
• Target: 45
• Locations: 11 countries
• Sites: 34

Brief Summary

The primary objective of this study is to evaluate the efficacy of treatment with either lulizumab or BMS-986142 versus placebo in subjects with moderate to severe primary Sjögren's syndrome as measured by the change from baseline in ESSDAI at Week 12 between active treatment arms (lulizumab or BMS-986142, respectively) and the placebo arm.

Conditions

Sjögren's Syndrome

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in ESSDAI

  The ESSDAI is a clinical index that measures Sjogren's syndrome disease activity. A physician scores the disease activity level of twelve organ-specific domains in 3 or 4 levels according to their severity. For example, for no disease activity the domain score equals 0 and for high disease activity the domain score equals 3 or 4. Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. The sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates more disease activity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening

  At baseline and week 12

Secondary Outcomes (19)

• Mean Change From Baseline in ESSDAI Scores at Week 4 and Week 8

  At baseline, week 4 and week 8

• Mean Change From Baseline in ESSPRI Score at Week 4, Week 8, and Week 12.

  At baseline, week 4, week 8, and week 12

• Proportion of Subjects With a > = 3 Point Improvement From Baseline in ESSDAI at Week 12

  At week 12

• Proportion of Subjects With Both >= 3 Points Improvement in ESSDAI and >= 1 Point Improvement in ESSPRI From Baseline at Week 12

  At week 12

• Proportions of Subjects With >=1 Point of Improvement From Baseline in ESSPRI

  At week 12

Study Arms (3)

BMS-931699

EXPERIMENTAL

Subcutaneous weekly injection + daily oral placebo tablets

Drug: BMS-931699; Drug: Placebo

BMS-986142

EXPERIMENTAL

Daily oral tablets + subcutaneous placebo (weekly) injection

Drug: BMS-986142; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Weekly subcutaneous placebo injection +daily oral placebo tablets

Drug: Placebo

Interventions

BMS-931699 DRUG

Specified dose on specified days

Also known as: lulizumab

BMS-931699

BMS-986142 DRUG

Specified dose on specified days

BMS-986142

Placebo DRUG

Specified dose on specified days

BMS-931699; BMS-986142; Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects diagnosed or classified as having moderate to severe primary Sjögren's Syndrome based on the 2016 ACR-EULAR Sjögren's Syndrome Classification Criteria for at least 16 weeks prior to screening
• ESSDAI ≥ 5 including disease activity (any score \> 0) in at least one of the following domains: Glandular, Articular, Hematological, Biological, Lymphadenopathy
• Positive anti-SS-A/Ro and/or anti-SS-B/La autoantibody
• Unstimulated whole saliva secretion \> 0.01 ml/min
• Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug and must not be pregnant or breastfeeding. Male and female subjects must be willing to adhere to protocol-mandated highly effective contraception for the duration of the study and for the protocol-specified follow up period. Hormone-based contraceptive methods are not permitted

You may not qualify if:

• Secondary Sjögren's syndrome or the presence of any other systemic autoimmune disease (eg, RA, SLE, multiple sclerosis, vasculitis)
• Very severe primary Sjögren's syndrome or severe complications of primary Sjögren's syndrome at the time of the screening visit
• Active systemic or latent bacterial (including tuberculosis), viral or fungal infection, evidence of current or chronic Hepatitis B or C infection, or HIV infection
• Any significant concurrent medical condition at the time of screening or baseline visit
• Use of methotrexate, cyclophosphamide, cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil (MMF) or leflunomide within 12 weeks of screening visit
• Previous treatment with biologics therapies either marketed or in development within 6 months prior to screening visit
• Treatment started or an unstable dose of hydroxychloroquine within 8 weeks of screening visit
• Oral corticosteroids \> 10 mg/day within 14 days of dosing (Day 1), corticosteroid therapy ≥ 1 mg/kg during the 4 weeks preceding enrollment, or intravenous, intramuscular or intra-articular corticosteroids within 4 weeks of screening visit

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (34)

St Joseph Heritage Healthcare

Fullerton, California, 92835, United States

Location

Local Institution

Palo Alto, California, 94304, United States

Location

Local Institution

Sarasota, Florida, 34239, United States

Location

North Georgia Rheumatology Group

Lawrenceville, Georgia, 30096, United States

Location

Clinical Pharmacology Study Group

Worcester, Massachusetts, 01605, United States

Location

Local Institution

Tupelo, Mississippi, 38801, United States

Location

Arthritis And Osteoporosis Associates, Pa

Freehold, New Jersey, 07728, United States

Location

New Mexico Clinical Research & Osteoporosis Center

Albuquerque, New Mexico, 87109, United States

Location

Local Institution

Mineola, New York, 11501, United States

Location

Pmg Research Of Wilmington Llc

Wilmington, North Carolina, 28401, United States

Location

Paramount Medical Research & Consulting, Llc

Middleburg Heights, Ohio, 44130, United States

Location

Altoona Center For Clinical Research

Duncansville, Pennsylvania, 16635-8406, United States

Location

Local Institution

Philadelphia, Pennsylvania, 19104, United States

Location

Local Institution

Wexford, Pennsylvania, 15090, United States

Location

Acme Research, Llc

Orangeburg, South Carolina, 29118, United States

Location

West Tennessee Research Institute

Jackson, Tennessee, 38305, United States

Location

Tekton Research Inc

Austin, Texas, 78745, United States

Location

Local Institution

Camperdown, New South Wales, 2050, Australia

Location

Local Institution

Santiago, Santiago Metropolitan, 7501126, Chile

Location

Local Institution

Bogota, Cundinamarca, Colombia

Location

Local Institution

Bogotá, Colombia

Location

Local Institution

Cali, Colombia

Location

Azienda Ospedaliera Universitaria Pisana

Pisa, 56126, Italy

Location

Local Institution

Mexico City, Distrito Fededral, 11850, Mexico

Location

Local Institution

Guadalajara, Jalisco, 44650, Mexico

Location

Local Institution

Mérida, Yucatán, 97070, Mexico

Location

Local Institution

Veracruz, 91910, Mexico

Location

Local Institution

Lima Cercado, Lima region, 1, Peru

Location

Local Institution

Lima, LIMA 31, Peru

Location

Instituto De Ginecologia Y Reproduccion Inv. Clinical Sac

Lima, LIMA 33, Peru

Location

Klinika Reumatologii i Chorob Wewnetrznych

Wroclaw, 50-556, Poland

Location

Local Institution

San Juan, 00909, Puerto Rico

Location

Local Institution

Moscow, 121374, Russia

Location

Local Institution

Stellenbosch, Western Cape, 7600, South Africa

Location

Related Links

• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form

MeSH Terms

Conditions

Sjogren's Syndrome

Interventions

lulizumab pegol

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2016
• First Posted: July 26, 2016
• Study Start: October 18, 2016
• Primary Completion: July 24, 2017
• Study Completion: July 24, 2017
• Last Updated: October 4, 2018
• Results First Posted: October 4, 2018

Record last verified: 2018-10

Locations

CL (1); PL (1); PR (1); RU (1); CO (3); ZA (1); ME (4); AU (1); PE (3); US (17); IT (1)